Since primary users of point-of-care (POC) devices are health professionals from a non-laboratory background, POC clinical analyzers should be designed for ease of use, low maintenance, and well-controlled. A key requirement in developing such a system is having a total quality assurance (QA) program with the capability to detect errors during each stage of the testing process, that is, pre-analytical, analytical and post analytical.
The Intelligent Quality Management (iQM) in the GEM Premier line of automated clinical analyzers for measurement of blood gases, electrolytes, metabolites and CO-Oximetry produced by Instrumentation Laboratory of Bedford, Mass. is an example of such comprehensive QA program. The primary method of error detection is based on monitoring sensor drift by the process control solutions and using drift limit as control parameter for detecting errors. The source of error, such as interfering substances and blood clots, is detected through identifying specific known drift patterns.